During clinical trials, the most frequently reported adverse event in the Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% and vehicle groups.

Local Adverse Events - all causalities in >/= 1% of patients

Clindamycin Phosphate and BenzoylPeroxide Gel, 1%/5%n = 420

Vehiclen = 168

Application Site Reaction

13 (3%)

1 (< 1%)

Dry Skin

50 (12%)

10 (6%)

Pruritis

8 (2%)

1 (< 1%)

Peeling

9 (2%)

-

Erythema

6 (1%)

1 (< 1%)

Sunburn

5 (1%)

-

The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies.

Anaphylaxis, as well as allergic reactions leading to hospitalization, have been reported during post-marketing use of clindamycin/benzoyl peroxide products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.